Expandable annuloplasty ring and associated ring holder

ABSTRACT

Devices and methods are provided for surgical repair of dilated aortic root to restore aortic valve competence while preserving native leaflets. In one aspect of the invention an expandable annuloplasty ring is provided for external placement at the base of a dilated aortic root. The expandable ring is capable of elastically expanding between a first diastolic diameter and a larger second systolic diameter to provide a physiologically representative surgical repair of the aortic root. In a further aspect of the invention, is provided a holder assembly for aortic annuloplasty ring and suitable for other cardiac valve prosthesis. The holder assembly consists of a holder body pivotingly coupled to a handle member through a ball-and-socket arrangement.

This application claims the benefits of U.S. Provisional PatentApplication Ser. No. 60/688,688 filed on Jun. 9, 2005.

FIELD OF THE INVENTION

The present invention relates to the field of heart valve surgery andassociated apparatus for holding cardiac valve prostheses during suchsurgical interventions. More specifically, the present invention isconcerned with an implantable annuloplasty ring for aortic valve repairand its associated ring holder assembly.

BACKGROUND OF THE INVENTION

Annuloplasty rings to repair cardiac valves have been used mostly formitral and tricuspid valve repairs. Such rings are implanted within theheart chambers and are as such in direct contact with patient's bloodflow.

Many designs of annuloplasty rings have evolved over the years. Somerings are completely closed while others are partially closed. Twoschools of thought still persist: one school advocates a rigid ring isbest to resize the mitral or tricuspid valve annulus, while a secondschool believes it is best to resize the annulus with a non-rigid orflexible ring. The latter rings, although being non-rigid or flexible,are however generally not elastic and are as such not expandable as afunction of the varying cardiac cycle parameters and associatedventricular mechanics. The latter rings passively comply to the desiredshape in which the surgeon implants them during the surgical repairprocedure, or if they are flexible may flex passively during the varyingphases of the cardiac cycle.

Annuloplasty rings for the aortic valve are currently not commerciallyavailable and generally not used. Some aortic annuloplasty ring conceptsplaced internally to the aortic root, in the vicinity of aorticleaflets, have been tried with little or no success in correcting aorticinsufficiency. This may be due to a number of reasons including therelatively more complex anatomy of the aortic valve annulus which iscoronet shaped (unlike the mitral and tricuspid annuli which aregenerally planar), and the dynamics of the aortic root which expandsconsiderably between the diastolic and systolic phase in the cardiaccycle.

Consequently, current aortic valve surgery is mostly dominated by valvereplacement procedures. More specifically, in treating aortic valveinsufficiencies due to an increasingly widespread range of pathologicalconditions (including Marfan disease, aortic annulo-ectasia, idiopathicroot dilations, bicuspid valve disease with associated aneurysm, andacute aortic dissection), very few aortic valve repair procedures arepractised to restore competence to the native aortic valve whilepreserving native leaflets. This is largely due to the technicallydemanding nature of current valve repair or sparing procedures such asthe most common “David Reimplantation” or “Yacoub Remodelling”.Moreover, due to the lack of a standardized technique that wouldadvantageously rely on enabling apparatus and cardiac prosthesisspecifically designed to facilitate the aortic valve sparing procedurewith a physiologically representative reconstruction, current surgicalinterventions are sometimes characterized by surgeon-dependent outcomes.Due to this lack of specially designed prosthesis and apparatus,practicing surgeons must often resort to “off-label use” of existingimplant materials to tailor a surgical solution during the surgicalintervention.

Due to the above drawbacks, even though a patient suffering from adilated aortic root may have viable valve leaflets, currently in thegreat majority of cases, the native valve and aortic root are removedand are replaced by a valved synthetic conduit in a procedure known asthe “Bentall” procedure. As a result, the patient's leaflets are notpreserved but are instead replaced by a prosthetic mechanical valve, andthe patient's dilated aortic root is not resized but removed andreplaced by synthetic conduit such as Dacron or ePTFE. One of the maindrawbacks of the Bentall procedure is that the patient is placed onlong-term anticoagulation therapy in Bentall procedures using mechanicalvalves, and a risk of valve degradation and need for re-operation inBentall procedures using a bioprosthetic valve.

In recent years, the scientific literature reflects a significant effortIn the medical research community directed not only to an understandingof the functional anatomy or physiology of the aortic valve and rootcomplex, but to the development of surgical repair techniques that areable to preserve viable native leaflets while correcting aorticinsufficiency. Such surgical repair techniques are commonly referred toas “valve-sparing surgeries”.

The valve sparing surgery commonly known as “David Reimplantation”involves the placement of a Dacron root prosthesis or synthetic aorticconduit over the scalloped native tissue, where it is sutured both belowthe valve leaflets through the valve annulus, and above the valveleaflets. The procedure is generally long and difficult to perform, andoften results in leaflet impact or concussion with the walls of theDacron prosthesis during the ejection phase of the cardiac cycle. Inaddition, the absence of radial compliance of the Dacron root prosthesisdoes not allow for an increase in diameter at the sinotubular junctionSTJ during ejection, which is an important aspect in providing optimalblood transport while preserving valve dynamics and valve leafletdurability. As such, the normal valve physiology is compromised in thisvalve-sparing intervention.

The second type of valve sparing operation, commonly known as “YacoubRemodelling”, involves scalloping the Dacron root prosthesis toessentially match the remaining native tissue, and using a runningsuture to attach the prosthesis to the native aortic root tissue.Although this method addresses some of the problems of thereimplantation method, it does not directly constrain the valve annulusdiameter, which has been seen to result in annular dilatation over time.As such, this procedure is not well suited for resizing a dilated valveannulus, and may be limited to replacing aneurysmal aortic tissue. Sinceit also relies on a Dacron vascular conduit, which is radiallynon-expansible, the expansion of the aortic root at level ofcommissures, in the plane joining the commissures or scalloped peaks ofnative tissue, tends to be constrained by the conduit fabric hoop. Assuch, the leaflet free edges are hindered in assuming their triangulatedrelationship, since the plane containing the sinotubular junction (STJ)is generally not expansible in this surgical procedure. Unlike thereimplantation procedure, however, the leaflets have a lower likelihoodof hitting the conduit wall since pseudo-sinuses may be fashioned from ascalloped Dacron conduit to recreate the pouch-like configuration seenin a healthy aortic root. Nonetheless, in the remodelling valve-sparingintervention, the normal native valve physiology is compromised, and theeffectiveness of resizing a dilated aortic annulus, or preventing itsfuture dilatation, with a scalloped vascular conduit remainsquestionable.

Although useful and widely accepted for some aortic reconstructionprocedures, conventional valve-sparing procedures and devicesnevertheless suffer from numerous drawbacks or shortcomings that aremanifested and become apparent both during the operative andpost-operative periods.

Accordingly, there exists a need for an improved aortic rootreconstruction procedure, and enabling devices, that allows correctionof a dilated aortic annulus (with associated replacement of aneurysmalaortic tissue when applicable), while preserving the native leaflets andmaintaining normal valve physiology. Typical prior art devices andmethods for aortic reconstruction or valve sparing interventions do notoffer a dynamic device configuration that may advantageously vary duringthe different phases of the cardiac cycle, and consequently restore orpreserve normal aortic valve physiology. More specifically, there existsa need for such an expandable annuloplasty ring which, when implanted,dynamically controls the valve annulus at the level of the aortic rootwhere it is implanted. Such an expandable annuloplasty ring wouldprovide the many benefits including: resizing of a dilated aortic rootor annulus in a physiologically representative manner, restoring nativeleaflet coaption and valve competence during diastolic phase of cardiaccycle, improved blood flow through the open aortic valve during thesystolic phase of the cardiac cycle, minimized stresses on nativeleaflets as they are cycled from their diastolic to systolicconfiguration. Also beneficial would be a procedure with reduced timeand difficulty relative to current valve sparing procedures.

Cardiac valve prostheses are generally mounted on a holder assembly tofacilitate their manipulation during the course of a surgicalintervention and their implantation. Current holder assemblies arecharacterized by a number of drawbacks.

A great majority of holders are configured with a rigid handle and afixed orientation of the holder body or prosthesis carrier relative tothe handle. Such a mechanical limitation does not allow the surgeon toorient the holder body relative to the handle in order to optimize thedelivery of the prosthesis to the implant site. Some holder assemblieshave been configured with malleable handles in an attempt to alleviatethis drawback. However, such malleable handles are generally difficultto reshape in different bent configurations once they have beeninitially bent. Moreover, the material of such malleable handles workhardens with repeat bending making it progressively more difficult toeasily bend such handles. As a result, some holder assemblies haveintroduced shape memory alloys, such as Nitinol, for the material of thehandle. Handles made from Nitinol that would be bent during the surgicalprocedure would resume their straight unbent shape after being exposedto sterilization temperatures. Some of the drawbacks associated withNitinol handles include cost, and generally insufficient stiffness ofsuch handles given the highly elastic properties of Nitinol. In order tomake Nitinol handles malleable and easy to bend into the desired shapeby the surgeon, such Nitinol handles are equally easy to bend out ofdesired shape when the cardiac prosthesis mounted on end of such handlesis exposed to tissue or suture loads during the surgical intervention.

A great number of holder assemblies are configured with a threadedinterface between the handle and the prosthesis carrier or holder. Suchthreaded interfaces do not provide the ability to orient the holder bodyrelative to the handle. As well, such threaded interfaces generally donot provide ability for rapid changeover of prosthesis holders orsizers, since unthreading and rethreading is a relatively lengthyprocess with inherent risks of cross-threading. Current alternatives tothreaded interfaces, such as quarter turn bayonet arrangements, are alsocurrently used but also do not offer the ability to orient the holderbody relative to the handle. Such bayonet arrangements are relativelylarge in size thereby creating greater obstruction to the surgeon viewof the surgical site. Such obstruction is particularly problematic whenthe surgeon is visually assessing the suitability of a selected size ofprosthesis. Also, bayonet arrangements are generally more difficult toclean and sterilize given the design of cooperating bayonet featuressuch as blind holes and elongated slots and dogs.

Another current technique for coupling the handle to the holder orprosthesis carrier consists of a tapered distal tip on the handle whichis pressed into a similar cooperating tapered opening in the holder.This provides a friction fit which may be separated by applying aseparation force between the holder and the handle. This technique doesnot provide a positive lock between the handle and holder (or sizer) andthe engagement forces may vary due to dimensional tolerances and wear atsuch interfaces. Moreover, it may be difficult to remove the holder fromthe handle when the holder is placed adjacent to the native valve duringthe surgical intervention, due to the variability in frictionalengagement and since the separating force must be applied to the holderin the chest cavity while the handle is pulled away from the holder awayfrom the chest cavity. Alternatively, the friction fit may be too looseresulting in holder (or sizer) easily disengaging from the handle makingfor an unsecure assembly. Other types of holder to handle interfacesrely on similar distal disengagement features whereby if the need todetach the handle from holder arises during the surgical procedure, thesurgeon generally needs to get inside the chest cavity to separate theholder form the handle.

Due to the current lack of suitable mechanical interfaces to allow rapidchangeover between different sizers and a common handle, and a secureengagement during the sizing intervention, current sizers are eachintegrally mounted to there own separate handle.

Accordingly, there exists a need for a holder assembly that resolves thedrawbacks associated with current holders. More specifically, there is aneed for a holder assembly that allows rapid quick changeovers. There isa need for holder assembly that allows the holder or prosthesis carrierto be variably mounted in a number of secure orientations relative tohandle so that the optimum mounting arrangement can be selected to suitthe specific anatomy of the patient, the specific anatomic routing ofthe surgical approach, or the surgeon work preference.

In accordance with the aortic annuloplasty ring of the present inventionthere exists the need for a specially designed holder assembly to mountan elastic or expansible annuloplasty ring in a mounting configurationthat is similar to a physiologic configuration that it will be exposedto in-vivo, such as physiologic configuration being different to thefree state configuration of the ring. Such a holder will allow thesurgeon to assess the suitability of a ring size while the ring is heldin an in-vivo configuration prior to removing the elastic ring from itsholder, and allowing it to resume its free state configuration.

SUMMARY OF THE INVENTION

The invention provides devices and surgical methods for performing valvesparing surgery of the aortic valve.

In accordance with a first aspect of the present invention, there isprovided an expandable annuloplasty ring for surgical repair of acardiac valve, the annuloplasty ring comprising: a first elastic coremember and a second elastic core member, the first and second elasticcore members held in general register and in a spaced apart relationshipto each other by a sheath member, the sheath member at least partiallyencapsulating a portion of each of said first and second core members,the annuloplasty ring being movable between a first diastolicconfiguration and a second systolic configuration wherein when theannuloplasty ring is in the diastolic configuration the annuloplastyring allowing resizing of a dilated aortic root so as to provideadequate coaption of valve leaflets contained within resized dilatedaortic root, and wherein when the annuloplasty ring is in the systolicconfiguration the annuloplasty ring is in an expanded perimeter relativeto the diastolic configuration allowing the valve leaflets within theaortic root to open; the annuloplasty ring movable between the first andsecond configuration by virtue of pressure changes that occur within theaortic root and muscle contractions that occur in the heart tissuesurrounding the annuloplasty ring as a function of the cardiac cycle.

The annuloplasty ring according to the present invention allows forsurgical reconstruction of a dilated aortic root while preserving nativevalve leaflets or cusps in a manner that is physiologicallyrepresentative. The implanted annuloplasty ring allows the native aorticroot and cardiac valve contained therein to generally retain theirdynamic behavior as a function of the variable pressures, musclecontractions, and blood flows associated with the dynamic cardiac cycle.

Furthermore, the annuloplasty ring according to the present invention isconfigured and sized to be implanted on the external surface of theaortic root, thus reducing the likelihood of thromboembolism and otherlike complications associated with internally-placed, blood-contactingannuloplasty rings.

Still furthermore, unlike internally placed annuloplasty rings whichrely on placement sutures between the ring and annulus to carry the loadassociated with resizing the valve annulus, the annuloplasty ring placedon the external surface of the aortic root acts as an external brace orhoop member. As such, the placement sutures between the annuloplastyring and aortic root serve mostly only to locate the ring axially,relative to the aortic root. The loads associated with resizing thedilated annulus are carried entirely by core members of the externallyplaced annuloplasty ring.

Still furthermore, the annuloplasty ring and associated ring holderaccording to the present invention are designed so as to facilitatecurrent valve sparing surgeries by providing a standardized valvesparing procedure through a set of quick and ergonomic steps.

In another preferred embodiment according to the first aspect of thepresent invention is provided a split annuloplasty ring whose free endsare subsequently joined to so that split ring behave as a full andcomplete annuloplasty ring. Such a split annuloplasty ring allows it tobe implanted at the base of the aortic root, below the level of the leftand right coronary ostia, without the need to detach the coronarybuttons. Such a split ring is particularly suited for valve sparingsurgeries without associated aneurysm of the aortic tissue and withoutresection of the Sinus of Valsalva tissue.

In a further aspect of the invention, a holder assembly for the aorticannuloplasty ring is provided. The holder assembly facilitates mountingof the aortic annuloplasty ring external to the aortic root, and isadvantageously provided with spaced apart suture access windows tofacilitate placement of ring fixation sutures. The holder assembly isadvantageously provided with a mechanical interface that pivotinglycouples a holder body, configured and sized for holding the aorticannuloplasty ring, and a handle member. The holder body may be orientedrelative to the handle member within a free range of orientations, andmay be locked in a predetermined spatial position within this range ofpossible orientations. The invention also provides for an actuatorcoupled to said handle for locking said holder body in saidpredetermined spatial position. The invention also provides for theholder to be detachable from said handle to allow changeover of holdersor prosthesis sizers from a common handle.

In further aspect of invention, the inventive features of the holderassembly may be advantageously applied to holder assemblies for othercardiac valve prostheses such as annuloplasty rings for mitral ortricuspid valve repairs, or to holder assemblies for cardiac valves(aortic, mitral, tricuspid valves either mechanical or bioprosthetic,and allograft or homograft if said latter graft valves are mounted to aholder body or carrier prior to surgical implantation). Morespecifically, a holder assembly for implanting a cardiac valveprosthesis is provided, said holder assembly comprising a holder bodyconfigured and sized for holding the cardiac valve prosthesis, and ahandle member configured to be gripped during the implantation of thecardiac valve prosthesis. The handle member also being pivotinglycoupled to the holder body through a ball-and-socket arrangement whereinthe holder body is pivotable relative to said handle in a desiredspatial orientation through said ball-and-socket arrangement.

In further aspect of invention, the inventive features of the holderassembly may be advantageously applied to cardiac valve sizers used forselecting the appropriate size of a cardiac valve prosthesis to beimplanted.

A further understanding of the nature and advantages of the inventionmay be realized by reference to the remaining portions of thespecification and the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the present invention will now be disclosed, byway of example, in reference to the following drawings in which:

FIG. 1 in a perspective cutaway view illustrates an expandableannuloplasty ring in accordance with an embodiment of the presentinvention for use in aortic valve sparing surgery;

FIGS. 2A-2C in top views of the annuloplasty ring of FIG. 1 illustratesthe variable diameter of the annuloplasty ring when exposed to varyinginternal pressures ranging from zero pressure at pre-implantation inFIG. 2A, diastolic pressure (@80 mmHg) in FIG. 2B, to systolic pressure(@120 mmHg) in FIG. 2C;

FIGS. 3A-3C in top views of the annuloplasty ring of FIG. 1 illustratesthe relationship of the variable diameter of the annuloplasty ring tothe aortic root and valve leaflets;

FIG. 4A in a schematic view illustrates a first alternative for a stitchpattern to assemble components of the annuloplasty ring according to thepresent invention;

FIG. 4B in a schematic view illustrates a second alternative for astitch pattern to assemble components of the annuloplasty ring accordingto the present invention;

FIGS. 4C-4G in schematic sectional views illustrate a variety of methodsfor configuring sheath and stitching patterns to assemble components ofannuloplasty ring according to the present invention;

FIG. 5 in a perspective view illustrates an annuloplasty ring holderthat may be advantageously used to implant the annuloplasty ring of FIG.1 according to the present invention;

FIG. 6 is a top view of the annuloplasty ring holder illustrated in FIG.5 illustrating in greater detail the feature of the detachable ringholder portion;

FIG. 7 in a perspective cutaway view illustrates the annuloplasty ringholder of FIG. 5 with the annuloplasty ring of FIG. 1 mounted theretoaccording to the present invention;

FIGS. 8A-8H illustrate a holder assembly for annuloplasty ring 10 aswell as the range of orientations provided by ball-and-socket mechanicaljoint 406;

FIGS. 9A-9B illustrate a variant embodiment for a ball-and-socketarrangement 506 between holder body 550 and handle member 505;

FIG. 10 illustrates a handle member 405 having an actuator 480 accordingto the present invention;

FIGS. 11A-11B illustrate a variant handle member 505 having a variantactuator 680 according to the present invention;

FIGS. 12A-12C illustrate further variants of the handle member 505illustrated in FIG. 11A;

FIGS. 13A-13B in top views illustrate the effect of having anon-expandable annuloplasty ring on the leaflet bending as a function ofthe cardiac cycle from diastole in FIG. 13A to systole in FIG. 13B;

FIGS. 14A-14D in schematic elevational views illustrate the implantationsteps of the aortic annuloplasty ring of FIG. 1 in a leaflet valvesparing surgery whereby a portion of aortic root has been removed andreplaced by a synthetic conduit;

FIG. 15A-15D in schematic elevational views illustrate the implantationsteps of a pair of aortic annuloplasty rings of FIG. 1 in a leafletvalve sparing surgery whereby the native aortic root has been preserved;

FIGS. 16A-16E in perspective views illustrate surgical steps associatedwith a valve sparing surgical procedure employing the annuloplasty ringof FIG. 1 and ring holder of FIG. 5 according to the principles of thepresent invention;

FIGS. 17A-17C illustrate the implantation steps of a split aorticannuloplasty ring in a leaflet valve sparing surgery whereby the nativeaortic root has been preserved;

FIGS. 18A-18B illustrate a split aortic annuloplasty ring according tothe present invention;

FIGS. 19A-19F illustrate a variety of methods for joining the splitaortic annuloplasty ring illustrated in FIG. 18A;

FIGS. 20A-20B illustrate a further variant for joining the ends of splitannuloplasty ring of FIG. 18A;

FIG. 21 illustrates a different embodiment for a double annuloplastyring surgery used with oversized vascular conduits to replace aneurysmalaortic tissue;

FIGS. 22A-22D illustrate the benefits a holder assembly illustrated inFIG. 5 advantageously applied to cardiac valve prosthesis in the natureof a mitral annuloplasty ring holders;

FIGS. 23A-23D illustrate the benefits a holder assembly illustrated inFIG. 5 advantageously applied to cardiac valve prosthesis in the natureof a tricuspid annuloplasty ring holders;

FIGS. 24A-24B illustrate the benefits a holder assembly illustrated inFIG. 5 advantageously applied to cardiac valve prosthesis in the natureof a mechanical heart valve;

FIG. 25 illustrate the benefits a holder assembly illustrated in FIG. 5advantageously applied to valve sizers for sizing an aortic valve duringvalve replacement surgery;

FIG. 26 illustrate the benefits a holder assembly illustrated in FIG. 5advantageously applied to valve sizers for sizing a mitral valve duringvalve repair surgery.

DETAILED DESCRIPTION

Referring to FIG. 1, there is shown an annuloplasty ring 10 inaccordance with an embodiment of the present invention. The annuloplastyring 10 is described herebelow and shown throughout the figures in thecontext of an aortic annuloplasty ring used to repair an aortic valvewith aortic insufficiency. It should however be understood that theexpandable annuloplasty ring 10 may offer advantages in other contexts,such as surgical repair of other cardiac valves like the pulmonaryvalve, without departing from the scope of the present invention.

In a preferred embodiment, annuloplasty ring 10 is comprised of a firstcore member 11 and a second core member 12. Each of said core members11,12 have a substantially annular shape and are preferably made from anelastic material such as silicone elastomer, polyvinyl-alcohol basedhydrogels or cryogels, polyurethanes, synthetic or natural rubbers, orany other like elastic materials suitable for implantation and capableof providing ring 10 with its expandable or expansible propertiesaccording to the principles of the present invention.

As illustrated in FIG. 1, each of core members 11,12 have asubstantially square cross-sectional area with rounded corners thatremains substantially constant around the perimeter of the core.Alternatively, core members 11 and 12 may be configured with differentcross-sectional areas. Alternatively still, the cross-sectional area maybe varied around the perimeter of said core members so as to provideincreased flexibility or stiffness at different sections of theannuloplasty ring perimeter. Yet alternatively still, the core members11,12 may be designed with a cross-sectional area that is circular,elliptical, triangular, rectangular, or any other like geometric shapewithout departing from the spirit of the present invention. Core members11,12 may also be reinforced by fibres or filament members in a suitablefibre-reinforced arrangement to provide an annuloplasty ring withnon-linear elastic behavior as a function of ring expansion.

The cross-sectional area of the core members 11,12 is derived anddepends on the material properties of the elastic material selected forsaid core members. For a given selected material, having acharacterizing modulus of elasticity, the cross-sectional area of thecore members 11, 12 may be sized for example to provide enough stiffnessto annuloplasty ring 10 to allow surgical resizing of a dilated aorticroot thereby restoring leaflet coaption and valve competence when theaortic root is exposed to the diastolic phase of the cardiac cycle, andsimultaneously to provide enough flexibility to allow controlledstretching of annuloplasty ring 10 as aortic root expands when exposedto the systolic phase of the cardiac cycle. The modulus of elasticity ispreferably in a range that will yield a ring cross-sectionalsufficiently compact to allow insertion of the annuloplasty ring belowthe coronary ostia, while also providing a ring with sufficient heightthat the resulting contact surface between ring 10 and the aorta issufficient to adequately buttress the dilated native annulus in itsresized diameter.

A preferred range of expansion of the annuloplasty ring 10 between thediastolic and systolic phase of the cardiac cycle is between 5 and 20%,and preferably between 8 and 15% and most preferably between 10 and 12%,thereby approximating the dynamic aortic root in a healthy patient.FIGS. 2A-2C and 3A-3C illustrate an example of the preferred embodimentof annuloplasty ring 10 for implantation at the base of the aortic root,having a systolic diameter D2 greater than the diastolic diameter D1 by10%, and the diastolic diameter D1 greater than the per-implantationdiameter D0 by 10%. It is understood that the same annuloplasty ring mayexpand by different amounts depending where on the aortic root it isimplanted. For instance, a ring implanted at the level of thesinotubular junction (STJ) will be exposed to different boundaryconditions than a ring implanted at the base of the aortic root.Consequently, the same ring will expand different amounts betweendiastole and systole depending on where it is implanted, that is, at theSTJ or at the base of the aortic root. As such, rings may be designedfor particular implantation locations by taking into account thedifferent boundary conditions they will be exposed to. Generally, theSTJ ring is exposed to smaller variations in cardiac cycle pressuresthan a ring at the base of the aortic root, which is influenced to agreater degree by the muscular contractions of the left ventricularoutflow tract (LVOT).

Referring to FIGS. 3B-3C, one of the benefits of having an expandableannuloplasty ring 10, relating to native leaflet stresses isillustrated. The proposed expandable annuloplasty ring 10, allowing theaortic root AR to expand in a controlled manner from its diastolicdiameter (FIG. 3B) to its systolic diameter (FIG. 3C), advantageouslyallows leaflet stresses to be reduced or minimized as leaflet freemargin LFM straightens from its obtuse-angle, L-shape configuration 19during the diastolic phase of the cardiac cycle, to a substantiallystraight configuration 20 during the systolic phase of the cardiaccycle. As such, the expansion of the aortic root AR as controlled ormodulated by the expanding annuloplasty ring 10 attached thereto, tendsto minimize the amount of cyclic bending that the leaflet free marginLFM is repeatedly exposed to during the cardiac cycle, thereby alsoreducing the bending stresses and improving long-term durability of thenative leaflets. Consequently, the native leaflets behavior issubstantially preserved by the surgical repair technique associated withan expandable annuloplasty ring 10, and consequently a resizing of thedilated aortic root may be achieved in physiologically representativemanner. In contrast, the effect of a non-expandable annuloplasty ring 66on leaflet stresses is illustrated in FIG. 8B. The non-expandableannuloplasty ring 66, constraining the aortic root AR from expanding(from its diastolic to systolic diameter), augments leaflet stresses asleaflet free margin LFM inflects its configuration from an obtuse-angle,L-shape configuration during the diastolic phase (FIG. 8A), to asubstantially double-S-shaped configuration during the systolic phase(FIG. 8B) of the cardiac cycle. The constrained aortic root ARrestricted by a non-expanding annuloplasty ring 66 attached thereto,increases the amount of cyclic bending that the leaflet free margin LFMis repeatedly exposed to during the cardiac cycle, thereby alsoincreasing the bending stresses and compromising the long-termdurability of the native leaflets. In addition, there exists a greaterrisk of leaflet concussion and erosion with a non-expandableannuloplasty ring 66 since the leaflet free margins LFM may contact theaortic root wall AR (or wall of synthetic conduit) during the systolicphase of the cardiac cycle.

Another benefit provided by expandable annuloplasty ring 10 relates tothe improved flow through area 99 across the aortic valve during thesystolic phase of the cardiac cycle. This improved flow through area 99is illustrated in FIG. 3C as the leaflet free margins LFM form asubstantially triangular opening. In contrast, the effect of anon-expandable annuloplasty ring 66 on flow through area 199 isillustrated in FIG. 8B. The systolic diameter D22 being substantiallyequal to the diastolic diameter D11 does not provide the increased flowthrough area that an expandable annuloplasty ring 10 provides as leafletfree margins LFM try to move radially outward within a constrainedaortic root.

In the preferred embodiment of annuloplasty ring 10, each of the coremembers 11,12 is covered by textile material or fabric sheath 16. Sheath16 is preferably sewn in a manner to enclose each of said core members11,12 in a separate textile channel 17,18, respectively. As such, sheath16 acts as a casing for core members 11,12, thereby serving to maintainthe spatial relationship between said core members. As illustrated,sheath 16 keeps core members 11,12 generally parallel and spaced apartrelative to each other. Alternatively, sheath 16 can be configured tokeep core members in a non-parallel spaced apart relationship.Alternatively still, sheath 16 can be configured with a slightundulation at one or more circumferential locations to allow betterseating of the annuloplasty ring at the base of the aortic root.

Sheath 16 is preferably designed not to hinder the core member expansionduring cardiac cycle and as such contributes very little or not at allto the overall stiffness or flexibility of ring 10. Sheath 16 may bedesigned to set the maximum limiting ring diameter that the annuloplastyring 10 will be able to assume, and as such provide a temporary failsafefeature in the event of a core failure.

Choice of sheath 16 materials include polyester, Dacron™, Goretex™ orother like textile materials that are knit (preferably) or woven in amanner that does not inhibit the expansion of core members 11,12 duringthe cardiac cycle (i.e. the physiologic range). Alternatively, sheath 16can also be made of expandable ePTFE, or elastomeric membrane exhibitingmuch greater flexibility than the elastic material selected for the coremembers 11,12. Alternatively, sheath 16 may be designed with limitedexpansibility so as to contribute to the overall stiffness andflexibility of annuloplasty ring 10. Alternatively still, sheath 16 maybe configured with varying expansibility as a function of the perimeterlocation, as for example with greater flexibility at the level of thenadirs and less flexibility proximal to the interleaflet triangles.

The portion of sheath 16 that maintains core members 11,12 in a spacedapart relationship advantageously provides a substantially annularsuturing zone 14. In the preferred embodiment of ring 10, as illustratedin FIG. 1, suturing area is a continuous substantially cylindricalsurface. Alternatively, suturing zone 14 may also be discontinuoushaving for example a plurality of fenestrations or openings extendingtherewithin. Suturing zone 14 may be advantageously delimited by twocircumferential stitch lines 13 so as to provide surgeon with visualmarkers clearly delineating the zone within which to place a pluralityof ring anchoring sutures, preferably U-stitches to anchor the ring tothe aortic root as described below. As such, the present inventionprovides an annuloplasty ring 10 having clearly identified suturing zone14 located between each of the elastic core members 11,12. Said suturingzone 14 is preferably clearly delineated by stitch lines 13 that arevisible both on the internal and external surfaces of ring 10. Anysuitable visible array of markers may be incorporated in ring 10 so asto assist the surgeon in adequately spacing an array of ring retentionsutures during the surgical intervention.

FIGS. 4A and 4B illustrate a first and second alternative for a stitchpattern 131, 132 that creates a stitch line 13 capable of providing aclearly delineated suture zone 14. In FIGS. 4A and 4B, bold linesrepresent the portion of stitch line 13 that is visible on the insidesurface of ring 10, while the light lines are visible on the outsidesurface of ring 10. In the preferred embodiment of ring 10, stitch line13 provides the closing seam to retain the elastic core members 11,12within their respective textile channels 17,18 while being sufficientlycompliant to not hinder or restrict the desired expansion of elasticcore members 11,12 during the phases of the cardiac cycle. Thecompliance of the stitch line 13 is also required to avoid transferringthe load from the expanding elastic core members 11,12 to sheath 16.Stitch lines 13 are preferably advantageously designed to not see any ofthe loads during annuloplasty ring functioning, and as such are lesslikely to contribute to a device failure.

FIGS. 4C-4G illustrate a variety of suitable methods for enclosingelastic core members 11,12 within sheath 16 in order to create acomposite ring structure 10. In each of the above variants, two stitchlines 13 serve to form an expandable seam according to the principles ofthe present invention.

An annuloplasty ring 10 having two distinct core members 11, 12separated by a suturing zone 14 provides the following advantages(relative to a single core annuloplasty ring covered by a textile sewingcuff):

-   -   Since ring anchoring sutures are placed between the two distinct        ring cores 11,12, substantially symmetrical loading of the        elastic core members 11,12 relative to the ring anchoring        sutures occurs during expansion of the aortic root, thereby        preventing any “rolling” of the elastic core members over the        ring anchoring sutures. Such an arrangement enhances ring        stability and propensity of ring to roll up along the aortic        root over the anchoring sutures as the aortic root pulsates.    -   The likelihood of piercing, nicking, or otherwise damaging an        elastic core member 11,12 by placing ring anchoring sutures        through the annuloplasty ring 10 is greatly reduced or        eliminated by having a clearly delimited suturing zone 14        located between said core members. This allows a more precise        prediction of durability and service life since puncturing an        elastic core member 11,12 with a securing suture during ring        implantation tends to affect the durability of the ring.    -   A clearly delimited suturing zone 14 leads to higher degree of        repeatability between procedures performed by one surgeon and        consistent standardized surgical method between surgeons.    -   A clearly delimited zone between core members 11, 12 results in        ease of suturability of the annuloplasty ring since anchoring        sutures may easily be passed through textile sheath in said        delimited zone by avoiding core members 11, 12.

To facilitate annuloplasty ring positioning during surgicalimplantation, ring 10 may be advantageously provided with a plurality ofpositioning indicators 15. As illustrated in FIGS. 1 and 6, three suchpositioning indicators 15 are provided as demarcations within sheath 16located 120 degrees apart from each other. Alternatively, ring 10 may beprovided with six equally spaced positioning indicators, or anyadvantageous number that will assist surgeon in strategic positioning ofring 10 relative to anatomic landmark within the aortic root, such as acommissure. Such features may be timed with features on the ring holderto facilitate the implantation procedure.

During aortic valve sparing surgery to preserve the native leaflets ofthe patient, it is convenient to implant the proposed annuloplasty ring10 over the diseased aortic root AR in the diastolic configuration (seeFIGS. 14C and 16D). Implanting the ring 10 as such, advantageouslyallows surgeon to assess leaflet coaption prior to closing aortotomyincision in ascending aorta. In the event of inadequate leafletcoaption, a different sized ring can be selected. Due to the elasticnature of the expandable ring 10, the free-state or pre-implantationdiameter D0 (FIG. 3A) is smaller in size than the diastolic diameter D1.As such, a specially designed holder assembly 100 is described accordingto the present invention that would advantageously allow ring 10 to beimplanted in its diastolic configuration over an aortic root AR to besurgically repaired (see FIG. 14C).

Holder assembly 100 consists of a handle member 105 and a detachablering holding member or ring carrier or holder body 150 coupled theretothrough mechanical interface or joint 106. Mechanical joint 106preferably includes a detachable ball-and-socket interface whichprovides advantages in the context of aortic annuloplasty ring 10, butalso in the context of other cardiac surgeries concerned with theimplantation of a cardiac valve prosthesis engaged with a holder body.Alternatively, other types of less versatile mechanical joints may beused in lieu of joint 106 including a threaded fitting connection, anexpanding collet, or any other like demountable mechanical couplingpermitting handle 105 to be advantageously mounted to and demounted fromring holding member 150 during the surgical procedure.

Referring to FIGS. 5-7, detachable ring holding member 150 consists of atop face or flange portion 120 and a cylindrical surface 130. Flange 120is configured with a plurality of scallops 102, and cylindrical surface130 is preferably configured with an equal number of suture accessapertures or windows or slots 101 substantially angularly aligned withsaid scallops 102. As illustrated, holder body 150 is configured withfive slots 101 and five scallops 102 (based on a pattern of six equallyspaced) to reflect the proposed method of suturing ring 10 to the aorticroot (five U-stitch sutures) as will be described in greater detailbelow. Other suturing arrays are also possible, depending on thesuturing method employed and the number of fixation sutures placed. Theholder body 150 may be also configured for alternate methods of ringfixation such as for instance stapling or use of shape memory clips suchas U-Clips™ provided by Coalescent Surgical Inc.

As illustrated in FIG. 6, ring 10 is kept in its diastolic diameter D1by being stretched form its pre-implantation diameter D0 and fit overcylindrical surface 130 and tangs 103. In addition, ring 10 is trappedaxially between flange 120 (and lugs 123 extending outwardly therefrom)and bent terminal ends 109 extend outwardly from ends of tangs 103.During manipulation of the holder assembly 100 in the surgicalprocedure, a retaining means in the nature of a plurality of ringretaining sutures 104 (three as illustrated in FIG. 7) serve to securering 10 to holding member 150. Each of the retaining sutures 104 isthreaded though a pair of holes 111 in lug 123 and also through a pairof cooperating holes 110 in tang 103 to form a continuous loop. This isone exemplary method of ring retention on holding member 150, and it isunderstood that other methods that hold ring 10 to holder body 150during the implantation procedure are possible, such alternate ringretaining methods also being removable or releasable or severable toliberate the ring 10 cut from the holder body after said ring has beenattached to the native aortic root. Scallops or recesses 102advantageously provide recesses for the surgeon's finger when tying downthe five U-stitch sutures that will anchor annuloplasty ring 10 to theaortic root. Each of the U-stitch sutures is preferably placed from theinside of ring 10 (through access slots 101 in suturing zone 14) andtied on the outside of ring 10 within suturing zone 14.

To detach ring-holding member 150 from annuloplasty ring 10 afterimplantation of said ring over diseased aortic root, the surgeon seversring-retaining sutures 104 by passing a scalpel blade along depressionof groove 107. Once all the retaining sutures 104 have been cut, andring 10 is secured to aortic root by tying down the plurality ofU-stitch sutures, holding member 150 is removed by pulling it upwardlyaway from aortic root generally in the direction of blood flow throughthe aortic root. An important design consideration is to configurecylindrical surface 130, and more importantly tangs 103 as thin aspossible to facilitate disassembly of ring 10 from holding member 150.Tangs 103 may be shortened or removed if additional sutures to hold ringto holder body are used, or additional windings of said sutures areplaced around the ring and holder body.

Alternatively, retaining means for ring onto holder may be retainingclips, or a pivoting leaf on a the holder or other releasable like meansthat can be cut or disengaged to liberate ring from its holder

Annuloplasty ring 10 is provided sterile and ready for implantation in avariety of classified sizes to cater to the different patient anatomies.For example, ring 10 may be provided in D1 sizes of 25 mm, 27 mm, 29 mm,31 mm and 33 mm. Accordingly, ring 10 is preferably mounted todetachable ring-holding member 150, which is also provided sterile andpackaged together with ring 10. The ring-holding member 150 may beformed using any appropriate manufacturing technique including molding,such as preferably injection molding, or it may be machined either as asingle piece or as an assembly of components that are joined.Preferably, the holding member is fabricated using a biocompatiblematerial such as polysulfone, polyphenylsulfone (such as Radel®),polyetheretherketone, acetal nitrile (such as Delrin®),polytetrafluoroethylene (PTFE), or any other suitable biocompatiblematerial capable of resisting the loads imparted from the annuloplastyring mounted on the holding member 150 in its diastolic configuration.

Handle member 105 may also be provided sterile or provided as areusable, re-sterilizable implement made from surgical-grade metalalloys.

In reference to FIGS. 8A-8H, a coordinate reference system X-Y-Z hasbeen drawn to more clearly describe the relationship between the figuresand components of the holder 450 and handle 405 cooperating at theball-and-socket joint or interface 406. Plane X-Y defines a prosthesisplane 451 located generally perpendicular to the direction of blood flowthrough prosthesis or annuloplasty ring 10 when it is implanted in thepatient's body. When a prosthesis is mounted to its holder body, forinstance ring 10 to holder 450, said prosthesis plane 451 also serves todefine a holder plane 452.

Ball or domed protrusion or spherical boss 453 is preferably formed asan integral part of holder body 450. It may be molded by plasticinjection as a protrusion preferably extending above top planar surface454 so as to allow unencumbered pivoting of handle 405 relative toholder 450. Also, such a boss arrangement does not interfere withannuloplasty ring 10 which is mounted below top planar surface 454. Aswell, such an arrangement reduces the likelihood of the boss 453 andhandle 405 distal end contacting the native aortic tissue NAR duringimplantation of ring 10.

Spherical boss 453 is provided with a spherical surface 455 which isconfigured and sized to cooperate with socket surface 456 on distal end457 of handle 405 to allow articulation therebetween and pivoting ofholder 450 relative to handle 405 at ball-and-socket joint 406.

Spherical boss 453 is interrupted by a tapered hole or passage 458extending toward the center of said boss. A countersunk depression 459also extending toward the center of said boss from a diametricallyopposite side. Tapered passage 458 and countersink 459 meet and arealigned, as illustrated in FIG. 8C, along the Z-direction.

Spherical boss 453 is interrupted by slot or passage 460 which alsointercepts tapered hole 458 and countersink 459. As illustrated in FIG.8A, said slot is aligned with the X axis and extends along Plane X-Z.Slot 460 is sized to allow cable 461 to move and pivot freelytherethrough as handle 405 pivots within a first pivot plane generallyaligned with slot 460 and extending through center point 462 ofspherical boss 453. As illustrated in FIGS. 8B and 8D, said first pivotplane 463 is Plane X-Z. As illustrated in FIG. 8D, a ball-and-socketarrangement 406 as described above will allow pivoting of handle 405relative to holder 450 within an exemplary range 464 of 120 degrees+/−30degrees. This is equivalent to holder 450 pivoting relative to handle405 with the same exemplary range, said pivoting occurring about a firstpivot axis 465 that is perpendicular to longitudinal axis 466 of thehandle 405. It is understood that slot 460 can have a differentorientation with respect to boss 453 and holder plane 452 than theorientation illustrated.

Tapered hole 458 provides an abutment or seat or shoulder 467 forterminal ball end 468 formed on end of cable 461. To engage holder 450on handle 405, terminal ball end 468 is inserted through passage oropening 458 while cable 461 simultaneously enters within slot 460.Tapered hole 458 is configured and sized to allow ball end 468 to beinserted sufficiently until center point 469 of ball 468 is coincidentwith center point 462 of spherical boss 453. The tapered surface 467 oftapered hole 458 extending above the centerline 470 of boss 453 and ball468 in FIG. 8C acts as a seat or socket for ball end 468. Taperedsurface 467 may be a spherical or a conical surface. Minimum dimensionof tapered hole 458 is smaller than diameter of ball end 468 to preventsaid ball end from slipping into countersink 459.

Boss 453 simultaneously acts as a “ball member” for cooperating socket456 in handle distal end 457, and a “socket member” for cooperating ball468 on cable 461 distal end. As such, the arrangement 406 advantageouslyprovides a pair of concentric ball-and-socket interfaces acting inparallel, to allow the range of free orientation between holder 450 andhandle 405. Such an arrangement also provides for the free rotation ofthe holder 450 relative to the handle 405 about the centerline axis 471of translating member or cable 461 (see FIGS. 8C and 8F). This rotationof holder 450 about centerline 471 can occur over an angular range of360 degrees, provided ball end 468 remains in engagement with seatportion 467 of tapered hole 458. In the embodiment illustrated in FIGS.8A-8H, centerline 471 is coincident with longitudinal axis 466 of handle405.

Other variants for a tapered hole are also possible without departingfrom the invention. For instance, tapered hole 458 may be replaced by acounterbored hole provided the shoulder of said counterbore locates ball468 within spherical boss 453 such that centerpoints 462, 469 of boss453 and ball 468 are substantially coincident.

With reference to FIGS. 8E and 8F, the range of motion or possibleorientations that the ball-and-socket arrangement can provide in anyother plane other than plane X-Z (i.e a first pivot plane 463) will nowbe described. In plane Y-Z as illustrated in FIG. 8F, the pivoting rangeof the holder 450 relative to the handle 405 is determined by theincluded angle of the countersink depression 459 and the difference indiameter of the cable 461 relative to the diameter of ball 468. Therange of articulation in plane X-Z translates to a conical volume 473 asillustrated in FIG. 8G, within which the handle 405 can free pivotrelative to holder 450. A ball-and-socket arrangement 406 as describedabove will allow pivoting of handle 405 relative to holder 450 within anexemplary range of orientations of 90 degrees+/−15 degrees. This saidexemplary range of orientations being defined by a conical volume havingan inclusive cone angle 474 and a vertex 475 at the coupling point 462between handle member 405 and holder body 450, with the handle memberlongitudinal axis 466 being contained within said conical volume 473when said handle member 405 is movable within said free range oforientations. This is equivalent to the holder 450 pivoting relative tohandle 405 with the same exemplary range. As such, the ball-and-socketarrangement 406 allows pivoting of holder body 450 about a secondpivoting axis 476, said second pivoting axis being perpendicular to eachof said first pivoting axis 465 and handle member longitudinal axis 466.

As illustrated in FIG. 8G, boss 453 has been configured to yield aconical volume 473 that is normal to the plane X-Y (i.e. or theprosthesis plane 451 or holder plane 452). It is understood that thevarying the orientation of said boss relative to plane X-Y, differentfrom that which is illustrated, may result in a conical volume which isnot perpendicular or normal to plane X-Y. As such, a different range oforientations of handle 405 relative to holder plane 452 may be provided.

Those skilled in the art will appreciate that the ranges of orientation(parameters of conical volume 473 in FIG. 8G) may be modified by varyingany one or a combination of the geometrical relationships such as thedifference between cable diameter 461 and ball end diameter 468, thedifference between cable diameter 468 and minimum tapered hole 458diameter, the included angle of countersink depression 459.

FIG. 8H illustrates the full or complete range of orientations androtations 479 between holder body 450 and handle member 405, as providedby one exemplary embodiment of the ball-and-socket arrangement 406. FIG.8H illustrates that the conical volume 473 described in FIG. 8G can beangularly swept through an angle 464, as cable 461 is able to movethrough slot 460 along plane 463, and while boss spherical surface 455and socket surface 456 remain in articulating contact.

Within the full range of orientations and rotations that are possiblebetween the holder and handle by virtue of ball-and-socket arrangement406, holder 450 can be secured or locked in a desired orientation orposition, within said range, through the actuation of translating memberor cable 461. Cable 461 may be retracted inwardly relative to seat 456in handle 405, and as such draw into progressively increasing frictionalcontact cooperating ball-and-socket surfaces 455,456 (between holder andhandle), and simultaneously cooperating ball-and-socket surfaces 468,467 (between actuator cable and tapered hole in boss). The amount offrictional contact provided by actuating cable 461 can be determined bythe design of actuator means 480 described below. A suitable surfacetexture treatment can also be advantageously provided betweencooperating ball-and-socket surfaces either to enhance frictiontherebetween and promote improved locking when actuator 480 is in alocked configuration, or to reduce friction therebetween so as tofacilitate ease of orientation of holder relative to handle whenactuator 480 is in an unlocked configuration.

A pivotingly coupled holder to handle embodiment through aball-and-socket joint 406, offers many distinct and unique advantagesover the prior art. These include a relatively compact and simple tofabricate functional joint with component interfaces that are easy toclean and sterilize. The enhanced range of orientations and rotationsbetween handle and holder provide great versatility in tailoring thesurgical set-up to suit the specific patient anatomy, the anatomicrouting of the holder as a function of the surgical approach or access,and the surgeon individual work preference. The ability to selectivelyand securely lock the holder relative to the handle in a desiredorientation provides a safe method of utilization. The ability toreleasably connect the holder to the handle allows the handle to beadvantageously decoupled from the holder during a phase of the surgicalintervention and reconnected during a subsequent phase. As well areleasable connection allows for rapid changeovers between differentholder sizes and/or different sizing implements with a common singleuniversal handle.

FIG. 9 illustrates a variant ball-and-socket interface 506 betweenhandle 505 and holder 550. Holder 550 defines a holder plane 509. Inthis embodiment, holder 550 is configured with an upstanding post 507extending away from top surface 514 of holder 550. Post 507 terminatedin a spherical ball end 508. Handle 505 is provided with a gate orentryway or passage 514 to allow ball 508 to engage seat or socket 512configured within hollow cavity in handle 505. Socket 512 is providedwith a spherical or conical surface that mates and cooperates withspherical surface of ball 508 thereby permitting relative articulationtherebetween. Said surfaces also cooperate to lock the orientation ofsaid holder relative to said handle when they are urged into frictionalcontact by translating member 513.

When post is aligned with slot 511 in handle 505, the holder canarticulate or pivot within a first pivot plane 510, said first pivotplane extends through said slot 511 and contains the center point ofball 508. Pivoting within said first plane is about axis 518 which isperpendicular to axis 517. When ball-and-socket arrangement 506 isunlocked, the holder can also rotate freely about the centerline axis517 of member 513, and can also pivot about a second pivot axis that isperpendicular to both handle axis 517 and first pivoting axis 518.Unlike the ball-and-socket arrangement 406, arrangement 506 is a singleball-and-socket arrangement and offers less range of orientation betweenholder and handle. It is also relatively more difficult to releaseholder body 550 from handle 505 given the lateral insertion of ball 508in entryway or slot 514.

Unlike preferred embodiment of FIG. 8A-8H, translating member 516 actsin compression to apply locking force to ball-and-socket interface 506.Translating member or rod 506 can be actuated by the same actuatorillustrated in FIG. 10, and similar actuator as illustrated in FIG. 11A.

As illustrated in FIG. 10, handle member 405 is generally elongate alonga longitudinal axis 466 and has a distal end 457 for connection to aholder body 450 and a proximal end 481 that is adapted to be gripped bythe surgeon during the surgical intervention.

Handle distal end 457 is configured and sized with a socket or seat 456to mate with cooperating boss 453 on holder body. Seat 456 is providedwith a concave spherical surface, or a conical depression, or any othersurface suitable to mate with boss 453 that allows articulationtherebetween but also locking therebetween when a contact pressure isexerted between said seat and boss.

The seat communicates with a channel or passageway 482 that extendslongitudinally through said handle body 483 between said distal end andproximal end. Channel 482 is sized to house and allow translationtherewithin of a translating member. Translating member can be a rod,shaft or preferably a cable 461. Cable 461 is provided at its distal endwith a terminal ball or spherical end 468 that is configured to beinsertable in tapered hole 458 and interface with tapered surface 467 ina manner describe above. Terminal ball end 468 is greater in diameterthan the cross-sectional dimension of the cable 461. At its proximal end484, said cable is provided with a threaded interface 485 andanti-rotation key 486. Preferably, thread 485 and key 486 and formed ona common fitting 487 that is attached to cable 461 through plasticinjection overmolding, or mechanically joined to said cable in apermanent manner. Cable 461 is insertable through proximal open end 481of handle and is preferably demountable to allow effective cleaning ofpassageway 482 after surgical use. Cable 461 may be provided sterile asa single use component.

Proximal end 481 of handle provided with a proximal actuator oractuation member 480 in the nature of a threaded control knob 489. Knob489 is rotatingly engaged to handle proximal end 481 through an axialretention member, such as bearing 490, which axially retains said knobbut allows it to rotate about handle or cable axis 466. Knob is providedwith an internal thread 491 configured to mate with cable externalthread 485. Handle body 483 is configured at it proximal free end withan anti-rotation slot or keyway 492. Said keyway is located intermediateto said knob thread 491 and bearing 490 when knob 489 is coupled tohandle 405. When cable is inserted through handle passageway 482, key486 will first engage keyway 492 and thread 485 with subsequently engagethread 491. As such, a rotation applied to knob 489 will result in cable461 translating through handle 405 since anti-rotation keyway 492 allowssliding engagement of key 486 but no rotation of cable 461.

Range of translational motion allows cable ball end 468 to extendsufficiently outwardly from seat 456 so as to engage tapered hole 458 inholder 450. Then, as said cable is retracted inwardly, the cooperatingsurfaces of mechanical joint 406 come into light contact allowing therelative articulation and rotation therebetween of the holder relativeto handle. As cable 461 is retracted further still, the contact forcebetween cooperating surfaces of joint 406 progressively increases andthe resulting friction at joint 406 securely locks the joint and theposition of holder 450 relative to handle 405.

As such, the actuator 480 is operable within a first actuation range toselectively release and engage the holder from the handle. Within asecond actuation range, as cable 461 is retracted further into thehandle passageway 482, the actuator 480 is also operable to selectivelysecure or lock the orientation between holder and handle at mechanicaljoint 406. By virtue of the threaded arrangement between actuator knob489 and translating actuating member or cable 461, the surgeon mayincrementally vary the contact forces and friction at mechanical joint406 so as to set precisely the amount of resistance desired to overcomesame and reorient the holder relative to the handle.

FIG. 11A-11B illustrates an alternate embodiment for a handle member 605having a variant actuator or actuation member 680 in the nature of alever member 689.

Handle member 605 is provided with a translating member 661 having aterminal ball end 668 at a distal end, and a clevis member 626 at theproximal end configured for rotating engagement with transfer linkage630 at a first joint. Transfer linkage 630 is rotatingly connected tolever 689 through a second joint 623. Lever 689 is connected to handleproximal end 631 through a leaf spring member 624 which biases saidlever into its open configuration 621 as illustrated in FIG. 11B, butallows said lever to pivot angularly about the end 631 of handle whensaid lever is depressed. In said open configuration, ball end 668extends sufficiently outwardly from seat 656 to allow said ball tobecome engaged in tapered hole 458 of holder body 450.

When actuation lever 689 is depressed, angular rotation of said leverentrains a rotation of transfer linkage 630 towards said lever andtranslating motion of member 661 along way 625 that retracts ball end668 towards seat 656. Continuing to depress lever 489 will laterallydisplace spring loaded latch 622 and result in lever being held in itsclosed configuration 620 (FIG. 11A) when said spring loaded latchrecoils over and above the lever 489. In said lever closedconfiguration, the ball 668 is sufficiently retracted towards seat 656to effectuate the locking of holder relative to handle 605. To unlockthe holder from the handle, either to reorient its position or torelease it from the handle, latch 622 is overcome by surgeon, therebyliberating the lever 689 to resume it biased open configuration 621 ofFIG. 11B. As such, actuator 680 is selectively operable between an openconfiguration 621 (FIG. 11B) allowing the holder to be coupled ordecoupled from the handle, and permitting the free orientation of holderrelative to handle, and a closed configuration 620 (FIG. 11A) securelylocking the holder relative to handle.

Handle 605 is provided with a cleaning or flushing port 627 to allowproper cleaning of handle without removing translating member fromhandle body.

FIG. 12A illustrates a further variant of embodiment of FIG. 11 havingan additional preferably non-detachable ball-and-socket joint 690,configured in series with the detachable ball-and-socket joint 406between holder and handle. This additional joint 690 advantageouslyprovides supplemental articulation range of the holder 450 relative tolongitudinal axis 466 of handle, over the articulation range defined byconical volume 473 defined in FIG. 8G. Such an arrangement allows thearticulation range to be increased without increasing the size of balland socket arrangement 406 to obtain a larger conical volume 473.

FIG. 12B illustrates yet a further variant of embodiment of FIG. 11having a predetermined permanent bend 691 in handle 692. Such anarrangement may be advantageous in certain surgical approaches, forinstance valve surgery performed by intercostal approach, where bend 691provides a desired anatomic routing for the handle 692 that avoidscertain body tissues while preserving variability in orientationsbetween holder and handle at distal end thereof.

FIG. 12C illustrates yet a further variant of embodiment of FIG. 11having an adjustable single or multiple complex bend 693 provided by aplurality of interconnected and cooperating sockets 694. Such anarrangement advantageously allows adjustability in the handleconfiguration depending on the desired anatomic routing or availablesurgical access in a given patient, or even to cater for surgeonpreference.

Referring to FIGS. 14A-14D and 15A-15D, annuloplasty ring 10,10′ isimplanted on the outside surface of aortic root AR. Two examples ofvalve leaflet sparing surgeries are illustrated. FIGS. 14A-14Dillustrate implantation of the proposed annuloplasty ring 10, in a planelocated generally below (i.e. below the valve cusps or leaflets) or atthe level of the aortic annulus, in a leaflet valve sparing procedureincluding resecting of an aneurysmal aortic root. As such, the diseasedaortic root 10 is scalloped prior to implantation of annuloplasty ring10 by surgically removing the diseased portion of aortic root thatdefines the Sinuses of Valsalva (i.e. located above the coronet-shapedaortic valve annulus ANN and generally below the plane of thesinotubular junction STJ) (see FIG. 14A). In this surgical procedure, asynthetic or prosthetic vascular conduit VC (i.e. as illustratedGelweave™ by Vascutek) is used to replace the portion of diseased aorticroot AR and ascending aorta that has been surgically resected. Thevascular conduit VC is fashioned or scalloped by the surgeon to matewith the remaining scalloped portion of native aortic root SAR. Thevascular conduit VC is attached to the scalloped aortic root SAR throughsuture line SL. Also in this procedure, the coronary buttons CB of theleft and right coronary arteries are reattached to the vascular conduitVC, in the scalloped portion of vascular conduit VC that recreatesneo-sinuses of Valsalva.

FIGS. 15A-15D illustrate implantation of the preferably two separateannuloplasty rings 10, 10′, in an aortic valve sparing procedure thatpreserves both the native valve leaflets and native aortic root NAR,while resizing the aortic root in order to correct aortic insufficiency.In this procedure, one ring 10 is implanted at the base of the nativeaortic root NAR in a plane located generally below the aortic annulus(i.e. below the valve cusps or leaflets), and one ring 10′ is implantedat the level of the sinotubular junction STJ. This procedure does notgenerally require the need for a synthetic or prosthetic vascularconduit. To avoid having to resect and re-attach the coronary buttons ofthe left and right coronary arteries, ring 10′ placed at the base of theaortic root is preferably configured with a mechanical joint 169 toallow its insertion below the coronaries, without departing from thespirit of the present invention.

With reference to FIGS. 18 to 20, the features of strip, band or splitring 10′ will now be described in greater detail below.

As illustrated in FIG. 18A, split ring 10′ consists of a unitaryelastomeric core 200 having a perimeter length approximately twice thecircumference of the eventual closed ring resulting when first 201 andsecond ends 202 of ring are joined.

Elastomeric core 200 consists of four segments 11′, 12′, 203, 204. Thecross-section of said segments of elastomeric core 200 is similar to thecross section of core members 11 or 12 in complete ring 10 described inFIG. 1. Stitch 13′ is similar to stitch 13 of complete ring 10. A methodof fabrication split ring 10′ includes inserting the elastomeric core200 in an elongate textile sheath 16′ provided with a suitable insertionopening that is sutured closed once core 200 is inserted therein. Stitch13′ may then be sewn in between top 11′ and bottom 12′ segments ofelastomeric core 200 along the length of split ring 11′. Stitch 13′terminates at a first 205 and second 206 tack, said tacks aiding to keepfirst 201 and second 202 end segments of elastomeric core 200 locatedrelative to textile sheath 16′ and from loading stitch 13′. An array ofmarkers 15′ may be provided in textile sheath 16′ in a spaced apartorientation to assist the surgeon in correctly placing thering-retention sutures that will serve to fix split ring 10′ to thenative aortic root NAR.

Various embodiments are possible for joining free ends 201, 202 of splitring 10′. FIG. 19A illustrates a glued mechanical joint 210. Split ring10′ is configured with two cooperating flaps 211, 212 of fabricextending longitudinally beyond terminal ends 201,202 of split ring 10′.Said flaps are preferably made from same fabric as textile sheath 16′.Each of flaps 211, 212 is connected or attached to its respectivereinforcement member 213, 214. When said flaps are joined,reinforcements 213, 214 ensure that the hoop stresses exerted on thejoined ring from the resized and pulsating aortic root are effectivelytransferred from the glued joint at joined flaps 211,212 to thereinforcements 213, 214 and consequently to end segments 203,204 ofelastomeric core 200. Any quick curing bioglue suitable for implantationin the human body, and for gluing textiles such as Dacron or ePTFE maybe used.

FIG. 19B illustrates a Velcro® type mechanical joint 220. Split ring 10′is configured with two cooperating members, a Velcro® hook member 221and a Velcro® loop member 222, each extending longitudinally beyondterminal ends 201,202 of split ring 10′. Each of members 221,222 isconnected or attached to its respective reinforcement member 223, 224for same reasons as mechanical joint 210 of FIG. 19A. A Velcro®mechanical joint 220 advantageously allows surgeon to detach andreattach ring free ends 201, 202 during the surgical process. One of thecooperating members 222 or 221 may also be advantageously configuredwith longer length than its cooperating member 221 or 222 so as toprovide a degree of adjustability in setting the overall circumferenceof the joined split ring 10′. This feature provides some degree ofadjustability in allowing the surgeon to fine tune the leafletcoaptation in diastole.

FIG. 19C illustrates a mechanical joint 230 that is joined by a filamentmember or thread 233. Ends 201, 202 of ring 10′ are configured witheyelets 231, 232 to evenly distribute the closing load provided bythread 233 over the elastomeric end segment 203, 204 respectively.

FIG. 19D illustrates a mechanical joint 240 including a cooperating hookmember 241 and slot member 242. Hook member 241 is coupled to end 202through an eyelet or reinforcement member 244 serving to evenlydistribute the ring-closing load over the elastomeric end segment 204.Hook member 241 extends away from end 202 and is configured to engage onof the plurality of slots 242 in end 201 of split ring 10′. Slots 242are configured in reinforcement or insert or plate 243 serving to evenlydistribute the ring-closing load over the elastomeric end segment 203.The plurality of slots 242 provides a degree of adjustability in settingthe overall circumference of the joined split ring 10′

FIGS. 19E-19F illustrate a mechanical joint 250 including a cooperatingplug member 254 and eyelet or catch member 251. Insertable plug member254 is configured on a plate 255 which extends from end 202. Plug member254 is coupled to end 202 through an assembled and permanently attachedplug 252 serving to evenly distribute the ring-closing load over theelastomeric end segment 204. Plug 254 may be provided with a filament orthread member 253 extending therefrom to help surgeon guide said pluginto engagement into cooperating eyelet 251. Plug 254 is configured witha deformable conical enlargement 256 to help guide it through eyelet 251and once inserted to prevent it from being released from eyelet 251. Assuch, a secure and safe mechanical joint is achieved. Eyelet 251 issized to evenly distribute the ring-closing load over the elastomericend segment 203.

FIG. 20A illustrates a mechanical joint 260 including a separatecoupling member 261 cooperating with eyelets 262, 263 in each of freeends 201, 202. Coupler 261 is preferably preformed in a U-shapedconfiguration having a spacing between members 268, 269 suitable toengage eyelets 262, 263. Coupler 261 is preferably provided withfilament members or flexible guides or sutures 264, 265 extending fromfree ends of members 268, 269 to help surgeon guide coupler intoengagement with respective eyelets 262, 263. Once engaged with saideyelets, coupler 261 is deformed to create bent over tabs 266, 267 thatprevent disassembly of joint. Tabs 266, 267 may be deformed by asurgical tool, forceps, or may be preferably self-deforming by virtuetheir shape memory alloy properties. Another example of a preferredembodiment for coupler 261 in nature of self-closing clip is describedand illustrated in FIG. 9 of U.S. Pat. No. 6,921,407 to Nguyen.

In use, when the free ends 201, 202 of split ring 10′ are coupled orjoined by any one of the various embodiments described above, the loadsexerted by the resized and pulsating aortic root to the annuloplastyring will be essentially transferred to the elastomer core 200. Coresegments 11′, 12′ are in tension 209 by virtue of the effective loadtransfer occurring at the mechanical joints 208 (schematicallyrepresented in FIG. 18B) described hereabove. Other alternativeembodiments for split ring joints are also possible that effectivelytransfer the aortic root loads to the elastomeric core 200 when freeends 201, 202 of split ring 10′ are suitably joined, thereby ensuringthat the textile sheath 16′ and stitch 13′ are not load bearing members.As such, joined split ring 10′ behaves similarly to complete ring 10with textile sheath 16′ allowing substantially unhindered expansion ofelastomeric core 200 therewithin when it is exposed to cardiac cyclevariations. It is appreciated that the portion of the ring over jointlength 207 (schematically illustrated in FIG. 18B) may not be as elasticas the remainder of the ring outside this zone, as this depends on themechanical properties of the different mechanical joint concepts.

With reference to FIGS. 14A-14D and 16A-16E, in surgeries requiring theresection of aneurysmal aortic tissue, an example of the implantationprocedure for the proposed annuloplasty ring 10, includes the followingsteps:

-   -   measure the diameter of the ascending aorta (AA), diameter of        the base of the aortic annulus, and wall thickness of the aortic        root;    -   resect away the area surrounding the AA, leaving the aorta free        from the pulmonary artery;    -   trim back the AA to about 5 mm above the commissure peaks;    -   scallop the aortic root tissue, removing aneurysmal Sinus of        Valsalva tissue and leaving a fringe of aortic root tissue        extending approximately 3 to 5 mm above the leaflet junction or        leaflet insertion line;    -   separate the left ventricular outflow tract (LVOT) away from the        base of the aortic root as far down as possible until muscular        tissue is exposed;    -   resect the coronary ostia from the resected Sinus of Valsalva        tissue and preserve for later reimplantation;    -   at the top of each commissure, pass three mobilization sutures        to help mobilize resected aortic root and aortic valve        mechanism;    -   in a subvalvular plane approximately 1 mm below the leaflet        insertion line, pass five ring securing sutures. Three of the        sutures 901, 903, 905 are aligned with each of the leaflet        nadirs, one of the sutures 902 is placed at the base of the        interleaflet triangle ILT between the left and right leaflet        cusps, and one of the sutures 904 is placed between the left and        non-coronary leaflet cusps.    -   preferably, ring securing sutures 901, 902, 903, 904, 905 are        inserted from the inside of the subvalvular apparatus as        U-stitches, and emerge from the ventricular tissue approximately        5 mm away from the outer aortic wall tissue. This distance is        desirable in order to leave enough clearance for seating the        ring, thus ensuring its position as low as possible on the left        ventricular outflow tract. A ring securing suture is preferably        not placed in the interleaflet triangle ILT between the right        and non-coronary leaflet cusps in order to avoid potential        interference with the AV node of bundle of HIS.    -   place three graft-securing sutures 909, 910, 911 aligned with        the nadirs, above the leaflet insertion line 912, and pass        through the scalloped aortic root fringe 913. These sutures are        placed as U-stitches, going from the inside to the outside of        the aortic root, as seen in FIG. 16A.    -   make three equally spaced cuts along the three vertical axial        side marks of a vascular prosthesis VC such as a Gelweave        Valsalva (Vascutek Terumo Inc.), extending up to the junction        line joining the vertical and horizontal pleats of the vascular        conduit (in aortic valves with approximately equally spaced        commissures and leaflet sizes);    -   scallop the vascular conduit to recreate three pseudo-sinuses of        Valsalva 914;    -   suture the scalloped vascular conduit to the native scalloped        aortic root 915. Sutures are preferably placed along the aortic        root tissue fringe, running from the nadir to the commissure        (i.e. repeated 6 times), thereby always maintaining the sewing        direction from the inside of the aortic root to the outside in        order to avoid the risk of leaflet puncture, to ensure accurate        and consistent suture placement with respect to leaflets, and to        reduce the likelihood of bunching up vascular conduit at        commissure location;    -   tie knots between adjacent sutures at the commissure location;    -   once the vascular conduit has been completely sutured to the        scalloped portion of the native aortic root, the five ring        securing sutures (i.e. U-stitches) are passed through the        annuloplasty ring 10 from the inner to the outer surface,        through each of suture windows 101;    -   descend the annuloplasty ring 10 through manipulation of holder        assembly 100 in a manner to set ring 10 firmly in place at the        base of the aortic valve annulus, or slightly therebelow;    -   holder assembly 100 is oriented such that the mechanical joint        106 is aligned with the AV node. Since there is no U-stitch        suture in this location, this ensures that no ring securing        sutures are placed in this region;    -   tie knots at the location where each of the five ring-securing        sutures extend through the ring 10;    -   reimplant coronary button CB containing the native coronary        ostia to the vascular conduit in the location of the new        pseudo-sinuses.

With reference to FIGS. 15A-15D and 17A-17C, in surgeries not requiringthe resection of aneurysmal aortic tissue, an example of theimplantation procedure for the proposed annuloplasty ring 10, includesthe following steps:

-   -   cut the ascending aorta (AA), approximately 10 mm above the        sinotubular junction (STJ);    -   measure the diameter of the ascending aorta, diameter of the        base of the aortic annulus, diameter of the sinotubular junction        and wall thickness of the aortic root;    -   resect away the area surrounding the AA, leaving the aorta free        from the pulmonary artery;    -   separate the left ventricular outflow tract (LVOT) away from the        base of the aortic root as far down as possible until muscular        tissue is exposed;    -   create a space 920 between the right coronary artery and the        base of the aortic root, directly below its point of departure        from the right coronary sinus, such that the open ring can be        fed through the space;    -   repeat the previous step for the left coronary artery, creating        a space 921 between the left coronary artery and the base of the        aortic root;    -   in a subvalvular plane approximately 1 mm below the leaflet        insertion line, pass five ring securing sutures. Three of the        sutures 901, 903, 905 are aligned with each of the leaflet        nadirs, one of the sutures 902 is placed at the base of the        interleaflet triangle ILT between the left and right leaflet        cusps, and one of the sutures 904 is placed between the left and        non-coronary leaflet cusps.    -   preferably, ring securing sutures 901, 902, 903, 904, 905, 906,        907 are inserted from the inside of the subvalvular apparatus as        U-stitches, and emerge from the ventricular tissue approximately        5 mm away from the outer aortic wall tissue. This distance is        desirable in order to leave enough clearance for seating the        ring, thus ensuring its position as low as possible on the left        ventricular outflow tract. A ring securing suture is preferably        not placed in the interleaflet triangle ILT between the right        and non-coronary leaflet cusps in order to avoid potential        interference with the AV node of bundle of HIS, but can be        placed if desired 922.    -   preferably, two of the five ring securing sutures 904 and 905        corresponding to the non-coronary leaflet nadir and the        interleaflet triangle ILT between the left and non-coronary        leaflet cusps, are passed through the space between the left        coronary and the base of the aortic root;    -   pass the ring securing sutures (i.e. U-stitches) through the        appropriate locations on the inner aspect of the open ring 923;    -   preferably, ring closing sutures 924 are placed through the        right coronary end of the open ring prior to ring placement        around the aortic annulus in order to avoid having to perform        this step in situ;    -   pass the appropriate end of the ring 926 through the space        between the left coronary and the base of the aortic root 921,        ensuring that tension is maintained in the ring securing sutures        to avoid tangling during placement;    -   pass the ring closing sutures and remaining end of the ring 925        through the space between the right coronary and the base of the        aortic root 920, ensuring that tension is maintained in the ring        securing sutures to avoid tangling during placement;    -   pass the ring closing sutures through the opposite end of the        ring 926, pull the two ends of the ring together, tie knots, and        trim the suture leads such that the ends of the ring are        touching each other but not crimped or overlapping, forming a        mechanical joint 169 between the two ends;    -   at this time the mechanical joint 169 of the two ends 925, 926        of the open ring should preferably lie approximately below the        interleaflet triangle ILT between the non-coronary and right        coronary leaflet cusps;    -   FIG. 15A shows another possible implantation orientation, where        the mechanical joint 169 of the two ends lies approximately        below the nadir of the right coronary leaflet cusp;    -   for each ring securing suture, remove slack by pulling the        suture tight, knot the two ends, and trim the suture leads;    -   at this point the annulus ring placement is complete, and the        STJ ring placement begins;    -   preferably, six ring securing sutures are placed in a plane        approximately 5 mm above the STJ, three directly above the        leaflet commissures 927, 928, 929, and three more equidistant        between the first three, such that when the ring is placed,        there is about 2 mm between the bottom of the ring and the        leaflet commissures, and about 2 mm between the top of the ring        and the cut edge of the ascending aorta to leave sufficient        exposed tissue for anastomosis of the ascending aorta;    -   six ring securing sutures (i.e. U-stitches) are passed through        the STJ annuloplasty ring 10 from the inner to the outer        surface, through each of the suture windows 101;    -   descend the annuloplasty ring 10 through manipulation of holder        100 in a manner to place the ring in a plane slightly above the        STJ;    -   for each of the six ring securing sutures, remove slack, tie        knots, and trim suture leads;    -   test valve competency by filling the valve leaflets with saline        solution and evaluating the characteristics of closure of the        valve;    -   cut the ring holder retaining sutures, and remove the ring        holder from the implantation site;    -   close the aortotomy by performing an anastomosis of the        ascending aorta.

With reference to FIG. 21, a different embodiment for a doubleannuloplasty ring concept is described. Unlike embodiment of FIGS.15A-15D which uses double annuloplasty in cases where aortic tissue isnot resected (i.e. aortic insufficiency without aneurysm of the aorta)this embodiment is suitable in cases where oversized conduits 941 areused to replace aneurysmal tissue and the resizing of both the base ofaortic root and sinotubular junction are achieved by separatecooperating annuloplasty rings 10. Such conduits 941 may be preparedprior to surgery with annuloplasty ring 10 already coupled to graft atlevel of STJ.

An externally placed annuloplasty ring 10, 10′ according to the presentinvention provides the following advantages:

-   -   since ring 10;10′ is placed on the outside of the aortic root,        ring core members 11,12;11′,12′ act as hoop members or brace        members to inwardly constrain body tissue. As such, core members        11,12; 11′,12′ carry substantially the entire mechanical load        associated with resizing a dilated aortic root (or aortic valve        annulus), and relatively few U-stitch sutures are required to        secure ring 10 to aortic root since said sutures only serve to        locate ring axially relative to aortic root.    -   No contact with patient's blood flow eliminates the likelihood        of thromoembolisms (or other such complications associated with        prosthetics in contact with blood flow) and reduces the        likelihood of post-implant infections.    -   Maximum flow-through area across the aortic valve, and minimum        impact of valve leaflet dynamics.

Internally placed aortic annuloplasty rings as described in the priorart are associated with numerous drawbacks, including the technicalchallenge of intravascular implantation in a manner to not interferewith leaflet motion. As well, ring fixation sutures are criticallystressed in internally placed aortic rings since the aortic annuluspulls away from the ring annulus during the systolic phase of thecardiac cycle. With internally placed annuloplasty rings the ring hoopstructure retains the native aortic root through the fixation suturesand does not provide a buttressing effect as does an externally placedannuloplasty ring according to the principles of the present invention.

FIGS. 22 and 23 refer to further aspect of the present invention. Thebenefits of a holder system or assembly 100 for aortic annuloplasty ring10 as described hereinabove may be advantageously applied to other typesof annuloplasty rings. FIG. 22A shows an exemplary embodiment of aC-shaped mitral ring 800. FIG. 22B shows an exemplary embodiment of aD-shaped mitral ring 801. Mitral rings 800, 801 are releasably connectedto a prosthesis carrier or holder body 850 through a ring retainingmeans such as a retaining suture (not shown). Holder body 850 isconfigured with a spherical boss or ball member 803 similar to ballmember 453 described in FIGS. 8A-8H. Holder body 850 is demountably andpivotingly coupled to handle member 804 through ball-and-socket typemechanical joint 806 according to the principles of the presentinvention as described in FIGS. 8A-8H. As such holder assembly 810benefits from the same inventive advantages as holder assembly 100.

FIGS. 23A and 23B show exemplary embodiments of open tricuspidannuloplasty ring 801. Tricuspid rings 811, 812 are releasably connectedto a prosthesis carrier or holder body 851 through a ring retainingmeans such as a retaining suture (not shown). Holder body 851 isconfigured with a spherical boss or ball member 813 similar to ballmember 453 described in FIGS. 8A-8H. Holder body 851 is demountably andpivotingly coupled to handle member 814 through ball-and-socket typemechanical joint 816 according to the principles of the presentinvention as described in FIGS. 8A-8H. As such holder assembly 820benefits from the same inventive advantages as holder assembly 100.

Unlike the aortic annuloplasty ring 10, rings 800, 801, 811, 812 aremounted within a heart chamber and as such ball member 803, 813 ispreferably located inwardly from the annulus of rings 800, 801, 811,812, and, in use, inwardly from the native valve annulus being repaired.

The holding assembly according to the principles of the invention may beapplied to any of the commercially available annuloplasty rings whoseimplantation may be facilitated by a holder and a handle coupledthereto. These include stiff or flexible rings, split or continuousrings, and those available in a variety of shapes including C-shaped,D-shaped, kidney-shaped, saddle-shaped, or non-planar shaped.

FIGS. 24A-24B refer to further aspect of the present invention. Thebenefits of a holder system or assembly 100 for aortic annuloplasty ring10 as described hereinabove may be advantageously applied to other typescardiac valve prostheses such as a mechanical heart valve 831. Valve 831defines a prosthesis plane 842. A typical holder body 852 suitable forreleasably holding a mechanical valve is illustrated. Body 852 isprovided with two cooperating half members 838, 837 which are pivotinglycoupled through joint 839. Members 838, 837 are each provided with atang 840, 841, respectively, to retain mechanical valve 831 when saidmembers are in their valve retaining configuration (FIG. 24A) and torelease said valve when said members are in their releasingconfiguration (FIG. 24B). Members 837, 838 are held in their retainingconfiguration typically by a filament or suture (not shown) which keepsfaces 843, 844 in contact. To release said cardiac valve from holderbody 852 after implantation the surgeon cuts said filament or suturethus allowing relative pivoting between members 837, 838.

A ball member 836 is configured atop one of said half members (837 asillustrated). Ball end 846 is insertable into passage 845 to pivotinglycouple holder 852 to handle 847. During the surgical procedure thesurgeon may adjust the orientation of the holder body relative to thehandle or even release said holder from handle to exchange size ofprosthesis, or even to changeover to a valve sizer implement instead ofthe holder body. To release the holder from the implanted valve 831, thehandle may be advantageously manipulated while it is locked with holderbody 852 along an angular motion 848 to facilitate the release of valve831 from holder body 852.

The holder assembly 830 allows surgeon select the most optimumorientation for handle 847 relative to valve 831 depending on thepatient's specific anatomy, type of valve being implanted, type ofsurgical approach being employed (i.e. intercostal, sternotomy, orsubxiphoid), or depending on surgeon work preference.

FIGS. 25-26 refer to further aspect of the present invention. Thebenefits of a holder system or assembly 100 for aortic annuloplasty ring10 as described hereinabove may be advantageously applied to otherimplements used in cardiac valve surgeries such as valve sizers used todetermine the size of annuloplasty ring in valve repair surgeries (FIG.26), or size of cardiac valve prosthesis in valve replacement surgeries(FIG. 25).

FIG. 25 illustrates a holding system or holder assembly 870 forreleasably mounting aortic valve sizers 871 during an aortic valvesurgery.

FIG. 26 illustrates a holding system or holder assembly 880 forreleasably mounting mitral valve sizers or template 881 during a mitralvalve repair surgery.

A holder assembly 870, 880 having a detachable holder and handleaccording to the present invention provides the surgeon with the abilityfor quick changeovers between different sizers, and eventually once sizeof prosthesis to be implanted is determined, a changeover from sizer tocardiac prosthesis, all changeovers being performed with a common handlemember.

The coupling between the distal tip of the handle and the prosthesisholder or sizer template should be such that the two may be easilyseparated from the handle when desired, while at the same time shouldremain securely attached to the handle to prevent unintentionalseparation therefrom during surgery. The holding system according to thepresent invention provides many advantages over the prior art techniquesallowing rapid changeovers between different sizing templates and/orprosthesis, offering variability in the range of orientation theprosthesis relative to handle may take, providing the ability to quicklyand securely lock the cardiac prosthesis holder relative to handle inmost suitable orientation for a given intervention.

1. A holder assembly for implanting a cardiac valve prosthesis, saidholder assembly comprising: a holder body, said holder body configuredand sized for holding said cardiac valve prosthesis, said holder bodyincluding a ball defined at least in part by an external sphericalsurface, said ball having an opening extending therethrough, saidopening extending through a center of said ball and provided with ashoulder member restricting the size of said opening, said ball alsohaving a slot extending from said external spherical surface inwardlytowards said center of said ball to communicate with said opening; and ahandle member, said handle member configured to be gripped during animplantation of said cardiac valve prosthesis, said handle memberincluding a socket seat configured and sized to mate with said ball,said socket seat and said ball cooperating to define together aball-and-socket arrangement, said handle member demountably coupled tosaid holder body through said ball-and-socket arrangement, said handlemember further comprising an actuator movable between a first and secondactuator configuration, said actuator being coupled to a translatingmember that is movable relative to said handle member when said actuatoris actuated, said translating member having a shaft portion and a shaftspherical terminal end enlarged in size relative to said shaft portion,said shaft portion sized to be insertable through said slot in said ballto allow demountable coupling of said holder body to said handle member,said shaft spherical terminal end being sized with a diameter largerthan said slot and configured to engage said shoulder member in saidholder body in a manner that when said holder body is coupled to saidhandle member, said spherical terminal end is positioned concentricwithin said ball; wherein, in said first actuator configuration saidholder body is pivotable relative to said handle member so as to bepositionable in a desired spatial orientation through saidball-and-socket arrangement, and in said second actuator configurationsaid holder body being locked relative to said handle member in saiddesired spatial orientation by virtue of said translating member drawingsaid ball into progressively increasing frictional contact with saidsocket seat as said actuator is moved between said first and secondactuator configuration.
 2. The holder assembly of claim 1 wherein saidhandle member is elongate and defines a longitudinal axis, in said firstactuator configuration said ball-and-socket arrangement allows pivotingof said holder body relative to said handle member about a firstpivoting axis, said first pivoting axis being perpendicular to saidhandle member longitudinal axis, said shaft portion moving angularlythrough said slot whilst said shaft spherical terminal end remainspositioned concentric within said ball while the holder body pivotsabout said first pivoting axis.
 3. The holder assembly of claim 2wherein said pivoting of said holder body about said first pivoting axisis within a pivoting range of 120 degrees +/−30 degrees.
 4. The holderassembly of claim 2 wherein said actuator is operable to selectivelylock said holder body in a fixed spatial relationship relative to saidhandle member longitudinal axis.
 5. The holder assembly of claim 2wherein said ball-and-socket arrangement allows rotation of said holderbody relative to said longitudinal axis of said handle member, and saidtranslating member is in tension when said actuator is in said secondactuator configuration.
 6. The holder assembly of claim 5 wherein saidholder body rotation is within an angular range of 360 degrees.
 7. Theholder assembly of claim 5 wherein said ball-and-socket arrangementallows pivoting of said holder body about a second pivoting axis, saidsecond pivoting axis being perpendicular to each of said first pivotingaxis and said handle member longitudinal axis.
 8. The holder assembly ofclaim 7 wherein, in said first actuator configuration, said handlemember is movable relative to said holder body within a free range oforientations and, in said second actuator configuration said handlemember is, lockable in a predetermined spatial position within saidrange of orientations, said range of orientations able to occur within aconical volume having an inclusive cone angle of 90 degrees+/−15 degreesand a vertex at a coupling point between said handle member and holderbody, said handle member longitudinal axis being contained within saidconical volume when said handle member is movable within said free rangeof orientations.
 9. The holder assembly of claim 8 wherein said cardiacvalve prosthesis defines an orifice through which blood will flow whensaid prosthesis is implanted and in use, said orifice defining aprosthesis plane, said conical volume defining a cone axis, said coneaxis being normal to said prosthesis plane when said prosthesis is heldby said holder body and said holder body is coupled to said handlemember.
 10. The holder assembly of claim 9 wherein said conical volumecan be angularly swept in a manner to pivot about said first pivotingaxis within a pivoting range of 120 degrees +/−30 degrees by virtue ofsaid shaft portion moving angularly through said slot whilst said shaftspherical terminal end remains positioned concentric within said ballthrough said pivoting range.
 11. The holder assembly of claim 8 whereinsaid free range of orientations is achieved by an articulation betweensaid external spherical surface on said holder body and said socket seaton said handle member, and a simultaneous pivoting motion of saidtranslating member relative to said ball, and whereby in said secondactuator configuration, said shaft terminal end engages said shouldermember bringing into locked contact said ball and said socket seatthereby locking said holder body relative to said handle member in saidpredetermined spatial orientation, within said free range oforientations.
 12. The holder assembly of claim 11 wherein said openingin said ball is a tapered hole and said translating member is a cablemember, said shaft terminal end is an enlarged cable ball end, saidshoulder member of said opening being formed by a minimum diameter ofsaid tapered hole, said tapered hole minimum diameter being smaller insize than the diameter defining said enlarged cable ball end.
 13. Theholder assembly of claim 12 wherein said ball defines a first ballcenter, said cable ball end defines a second ball center, said first andsecond ball centers being concentric so as to define a pair ofconcentric ball-and-socket interfaces; a first ball-and-socket interfacebeing disposed between said ball and said socket seat, a secondball-and-socket interface being disposed between said cable ball end andsaid shoulder member, said ball simultaneously cooperating with saidsocket seat, and with said cable ball end via said shoulder member,whereby said pair of concentric ball-and-socket interfaces act inparallel to allow said free range of orientations between said holderbody and said handle member.
 14. The holder assembly of claim 1 whereinsaid handle member is operable to selectively release said holder bodyduring the implantation of said cardiac valve prosthesis.
 15. The holderassembly of claim 1 wherein said handle member extends between a firstend and a second end along a longitudinal axis, said actuator beingdisposed generally adjacent to said first end, said socket seat providedgenerally adjacent to said handle second end, said translating membermovable generally along said longitudinal axis when said actuator ismoved between said first and said second configuration, wherein in saidsecond actuator configuration, said translating member secures said ballto said socket seat thereby locking said holder body to said handlemember in said desired spatial orientation.
 16. The holder assembly ofclaim 15 wherein said opening is a tapered hole, said shoulder member ofsaid opening being formed by a minimum diameter of said tapered hole,said tapered hole minimum diameter being smaller in size than thediameter defining said enlarged shaft spherical terminal end, saidtranslating member shaft portion extending beyond said second end, saidtranslating member shaft portion being releasable from said ball by areleasing movement through said slot, said releasing movementsimultaneously disengaging said shaft spherical terminal end from saidshoulder member, and said external spherical surface from said socketseat, thereby allowing rapid changeover of said holder body from saidhandle member.